CDSCO UID IMP/MD/2020/000533_619bbedf8b682cbeeb113fcf6ca27969_7f5ceedc302caf43eabaabe9b96db9b9

Delivery System(Cocoon Septal Delivery System- Cocoon Septal Occluder Accessory Set , Cocoon Duct Delivery System- Cocoon Duct Occluder Accessory Set , Cocoon Delivery Cable along with Components/ Accessories ASD Sheath/ PDA Sheath, ASD Dilator/ PDA Dilator, Loader, Hemostatis Valve)

M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India·Device Class Class D·India CDSCO·Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
Registration details
UID
IMP/MD/2020/000533_619bbedf8b682cbeeb113fcf6ca27969_7f5ceedc302caf43eabaabe9b96db9b9
Device class
Class D
Brand name
Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
Approving authority
CDSCO
Product information
It is intended for placement and if necessary retrieval of the device. Individual functions : 1. A delivery sheath with hemostasis valve adapter is used to deliver the device. 2. A dilator used to ease penetration of tissue. 3. A loader used to introduce the device into the delivery sheath 4. A delivery cable- the device is screwed onto the distal tip of the delivery cable, which allows for placement and retrieval of the device
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Delivery System(Cocoon PFO- Delivery System- Cocoon PFO- Occluder Accessory Set , Cocoon PFO- Delivery System- Cocoon Delivery Cable along with Components/ Accessories PFO Sheath, PFO Dilator, Loader, Hemostasis Valve)
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
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Septal Occluder(Cocoon Septal Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
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Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
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Duct Occluder(Cocoon Duct Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
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Sizing Balloon(Cocoon Sizing Balloon )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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Occluder(Cocoon PFO Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
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Transcatheter Aortic Valve
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
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Occluder(Cocoon VSD Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
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Other products from M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India
Products from the same license holder (8 products)
Delivery System(Cocoon PFO- Delivery System- Cocoon PFO- Occluder Accessory Set , Cocoon PFO- Delivery System- Cocoon Delivery Cable along with Components/ Accessories PFO Sheath, PFO Dilator, Loader, Hemostasis Valve)
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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Septal Occluder(Cocoon Septal Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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Delivery System(Cocoon VSD- Delivery System- Cocoon VSD Occluder Accessory Set / Cocoon VSD Occluder Accessory Set II , Cocoon VSD- Delivery System- Cocoon Delivery Cable including Cable Sheath along with Components/ Accessories VSD Sheath, VSD Dilator, Loader, Hemostasis Valve, Cable Sheath)
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
Class D
Duct Occluder(Cocoon Duct Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
Class D
Sizing Balloon(Cocoon Sizing Balloon )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
Class D
Occluder(Cocoon PFO Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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Transcatheter Aortic Valve
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
Class D
Occluder(Cocoon VSD Occluder )
Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System
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About this record

Delivery System(Cocoon Septal Delivery System- Cocoon Septal Occluder Accessory Set , Cocoon Duct Delivery System- Cocoon Duct Occluder Accessory Set , Cocoon Delivery Cable along with Components/ Accessories ASD Sheath/ PDA Sheath, ASD Dilator/ PDA Dilator, Loader, Hemostatis Valve) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000533_619bbedf8b682cbeeb113fcf6ca27969_7f5ceedc302caf43eabaabe9b96db9b9. This device is marketed under the brand name Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System. The license holder is M/s Vascular Concepts Ltd. ,K. No. 96-93-19, First Floor, S.V Complex, Bellary Road, Hebbal, Bangalore ,Bengaluru (Bangalore) Urban Karnataka ,560024 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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